Policy and Law
Liang BA,* Mackey TK. Stem Cells, Dot-Com. Sci Transl Med. 2012 Sept 12; 4;151:151-9.
Abstract. Direct-to-consumer (DTC) advertising of suspect goods and services has burgeoned because of the Internet. Despite very limited approval for use, DTC stem cell–marketed “treatments” have emerged for an array of conditions, creating global public health and safety risks. However, it remains unclear whether such use of stem cells is subject to drugs or biologics…
[...]Mackey TK, Liang BA*. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. J Pharm Sci. 2011 Nov;100(11):4571-9.
Abstract Counterfeit drugs are a global problem with significant and well-documented consequences for global health and patient safety, including drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of counterfeits is also wide in breadth and scope, including…
[...]Liang BA.*, Mackey TK. Promoting online drug safety: Using Public–Private Partnerships to Deter Illicit Online Drug Sales. J Commer Biotechnol. (2011) 17, 266–271
Illicit online pharmacies selling counterfeit drugs in a global virtual marketplace remain a critical problem in global health. Yet they continue to operate with little regulation while growing numbers of consumers access the Internet for health information that may lead them to purchase dangerous drugs online. This global social problem requires immediate action to protect…
[...]Danzon P, Johnson SJ, Long G, Furukawa MF. Commercial Importation of Prescription Drugs in the United States: Short-Run Implications. Journal of Health Politics, Policy and Law 2011 36(2):295-316.
The option of legalizing the commercial importation of prescription drugs is of continued policy interest as a way to reduce U.S. drug spending. Using IMS data, we estimate potential savings from commercial drug importation under assumptions about percentage of drugs likely to attract imports; potential supply from foreign countries; and share of savings passed on…
[...]Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825.
Direct-to-consumer advertising (DTCA) is legal only in the United States and New Zealand and has been linked with drug overutilization, public health concerns, and higher costs. 1 Despite global proscriptions, DTCA is the most rapidly increasing form of pharmaceutical marketing, with approximately $4 billion in US expenditures, outpacing physician marketing and research and development. Liang…
[...]Watson R. European Union prepares to tackle counterfeit drugs. BMJ. 2010;340:c2425.
European legislators are preparing new measures to clamp down on the sale of counterfeit drugs and to warn the public of the dangers of buying unauthorised drugs on the internet. The European parliament’s environment and public health committee has given overwhelming backing (51 members for, none against, and three abstentions) to moves to tackle the…
[...]Liang BA.*, Mackey T. Searching for Safety: Addressing Search Engine, Website, and Provider Accountability for Illicit Online Drug Sales. Am J Law Med. 2009;35:125-184.
Abstract.
Online sales of pharmaceuticals are a rapidly growing phenomenon. Yet despite the dangers of purchasing drugs over the Internet, sales continue to escalate. These dangers include patient harm from fake or tainted drugs, lack of clinical oversight, and financial loss. Patients, and in particular vulnerable groups such as seniors and minorities, purchase drugs online either naïvely or because they lack the ability to access medications from other sources due to price considerations. Unfortunately, high risk online drug sources dominate the Internet, and virtually no accountability exists to ensure safety of purchased products.
Importantly, search engines such as Google, Yahoo, and MSN, although purportedly requiring “verification” of Internet drug sellers using PharmacyChecker.com requirements, actually allow and profit from illicit drug sales from unverified websites. These search engines are not held accountable for facilitating clearly illegal activities. Both website drug seller anonymity and unethical physicians approving or writing prescriptions without seeing the patient contribute to rampant illegal online drug sales. Efforts in this country and around the world to stem the tide of these sales have had extremely limited effectiveness. Unfortunately, current congressional proposals are fractionated and do not address the key issues of demand by vulnerable patient populations, search engine accountability, and the ease with which financial transactions can be consummated to promote illegal online sales.
To deal with the social scourge of illicit online drug sales, this article proposes a comprehensive statutory solution that creates a nocost/low-cost national Drug Access Program to break the chain of demand from vulnerable patient populations and illicit online sellers, makes all Internet drug sales illegal unless the Internet pharmacy is licensed through a national Internet pharmacy licensing program, prohibits financial transactions for illegal online drug sales, and establishes criminal penalties for all parties—including websites, search engines, and health care providers— who engage in and facilitate this harmful activity.
[...]Bhan A. Health ministry institutes reward scheme for whistle-blowers reporting spurious drugs. Natl Med J India. 2010;23(1):56
In November 2009, the Ministry of Health and Family Welfare notified a new reward scheme for whistle-blowers who help unearth cases of spurious drugs.
[...]Alkahtani S, Sammons H, Choonara I, Epidemics of Acute Renal Failure in Children (diethylene glycol toxicity). Arch Dis Child. 2010 Dec;95(12):1062-4.
Acute renal failure in children can have a variety of causes. There have been several epidemics of acute renal failure affecting predominantly young children where the cause has been diethylene glycol (DEG) poisoning. These children have presented with gastrointestinal bleeding, seizures and liver failure as well as renal failure. The poisoning has been the result…
[...]Shepherd MD.* The effect of US pharmaceutical drug importation on the Canadian pharmaceutical supply. Can Pharm J. 2010 Sept/Oct; 143(5):226-33.
Abstract.
Background and objectives: For over a decade, many US politicians have advocated that the US allow personal and commercial drug importation. Currently, the only entities that can legally import a pharmaceutical in the US are pharmaceutical manufacturers. Our objective was to compare the number of prescriptions dispensed in Canada with the US and estimate the effect US drug importation from Canada will have on the Canadian drug supply.
Methods: A model was created to measure the potential effect on the Canadian drug supply. The model uses the number of US prescriptions being sourced from Canada and the number of prescriptions dispensed in Canada in 2007 as the baseline. The number of days to exhaust the 2007 Canadian drug supply was calculated.
Results: The model found that if 10% of the US prescriptions were fi lled from Canadian sources (manufacturer, wholesale or retail), Canada’s 2007 drug supply would be exhausted in 224 days. If the demand from the US reached 20%, the 2007 supply would be exhausted in 155 days. The model was redone focusing on brand name drugs, with generic drugs removed. It was found that with a US demand of 10% and 20%, the 2007 Canadian supply for brand name drugs would be exhausted in 268 and 201 days, respectively.
Conclusion: US drug importation is a threat to Canada’s drug supply. Even if the US demand were 10%, Canada would need to dramatically increase manufacturing, triple drug importation, or most likely control or halt pharmaceutical shipments to the US.
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